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Opioid Free Anesthesia and Major Spine Surgery

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ClinicalTrials.gov Identifier: NCT03417193
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hanane Barakat, Lebanese American University

Brief Summary:
This study compares the intraoperative opioid free anesthesia approach in multilevel spine posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine

Condition or disease Intervention/treatment Phase
Opioid Use Postoperative Pain Spine Disease Drug: opioid free Anesthesia vs Opioid based Anesthesia Not Applicable

Detailed Description:

Opioid analgesics are commonly used in clinical practice for per and postoperative pain treatment. However their use is associated with a lot of undesirable effects. From this comes the idea of using opioid free anesthesia intra-operatively in an attempt to decrease opioids postoperative use and accordingly, their associated side effects.

Intravenous (IV) lidocaine has been found to have analgesic, antihyperalgesic, and anti-inflammatory properties. It was found to significantly improve postoperative pain, when its intraoperative use was compared with placebo .

Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic, opioid sparing and sedative properties. Similar to lidocaine, dexmedetomidine was shown to lower postoperative pain, opioid consumption and accordingly, opioid related side effects.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opioid Free Anesthesia in Major Spine Surgery: a Prospective, Double-blinded, Randomized, Controlled Trial
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Active Comparator: Opioid based Anesthesia
General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl , sevoflurane and nitrous oxide.
Drug: opioid free Anesthesia vs Opioid based Anesthesia
Compare the opioid based anesthesia with Fentanyl and Remifentanyl to opioid free anesthesia with dexmedetomidine and lidocaine and their effect on postoperative pain.

Active Comparator: Opioid Free Anesthesia
-General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine , sevoflurane and nitrous oxide.
Drug: opioid free Anesthesia vs Opioid based Anesthesia
Compare the opioid based anesthesia with Fentanyl and Remifentanyl to opioid free anesthesia with dexmedetomidine and lidocaine and their effect on postoperative pain.




Primary Outcome Measures :
  1. Postoperative pain score [ Time Frame: 48 hours post operative. ]
    Measure the pain score using the Visual Analogue Scale (VAS), The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be' The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The score ranges from 0 to 100 mm. A higher score indicates greater pain intensity. The distribution pain is the following:no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 hours to be repeated every 6 hours thereafter up to 48 hours post surgery


Secondary Outcome Measures :
  1. Postoperative morphine consumption [ Time Frame: 48 hours ]

    After the surgery the patient will go to the PACU (Post Anesthesia Care Unit). the patient will receive morphine if the pain score is more than 4. the total dose of morphine in mg (milligrams) will be documented. Before discharge from the PACU, the patient will have a PCA (Patient Controlled Analgesia) morphine,All attempts and given values of morphine In mg obtained from the PCA machine will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours post surgery..

    And the total amount of morphine in mg will be calculated for 48 hours


  2. Postoperative morphine Side effects: Sedation score . [ Time Frame: 48 hours post operative. ]

    -Sedation score: 0 alert

    1. Mild, drowsy , easy to awake
    2. moderate, easy to arouse
    3. Severe: somnolent difficult to arouse 4:sleeping The Sedation score will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.

  3. Postoperative morphine Side effects:Respiratory depression [ Time Frame: 48 hours ]

    Assess the respiratory rate : The number of breaths per minute. In practice, the respiratory rate is usually determined by counting the number of times the chest rises or falls per minute.

    The respiratory rate will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.


  4. Postoperative morphine Side effects: Nausea vomiting [ Time Frame: 48 hours ]

    Degree of nausea vomiting using the verbal rating score from 0 to 10 : 0= no nausea/ Vomiting, 10: worst possible nausea vomiting.

    The degree of nausea vomiting will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.


  5. Postoperative morphine Side effects: Itching [ Time Frame: 48 hours ]
    Itching: presence or absence The presence or absence of itching will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age group: 18-80 years old
  • American Society of Anesthesiologists (ASA )class I and II
  • Elective spine posterior instrumentation surgery of at least two levels.

Exclusion Criteria:

  • Renal, hepatic or cardiac insufficiency.
  • Alcohol or drug abuse.
  • Psychiatric disease.
  • Allergy or contraindication to any of the study drugs.
  • Inability to comprehend pain assessment or inability to use a Patient Controlled Analgesia (PCA) device.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417193


Contacts
Contact: Hanane Barakat, MD +9611200800 ext 5168 hanane.barakat@lau.edu.lb
Contact: Vanda Abi Raad, MD +9611200800 ext 5168 vanda.abiraad@lau.edu.lb

Locations
Lebanon
LAU Medical Center Recruiting
Beirut, Lebanon
Contact: Hanane Barakat, MD    +9611200800 ext 5168    hanane.barakat@lau.edu.lb   
Contact: Vanda Abi Raad, MD    +9611200800 ext 5168    vanda.abiraad@lau.edu.lb   
Sponsors and Collaborators
Lebanese American University
Investigators
Principal Investigator: Hanane MD Lebanese American University/ LAU Medical Center

Responsible Party: Hanane Barakat, MD, Lebanese American University
ClinicalTrials.gov Identifier: NCT03417193     History of Changes
Other Study ID Numbers: LAUMCRH.HB1.11/Jan/2018
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hanane Barakat, Lebanese American University:
Lidocaine
Dexmedetomidine
Opioid-free

Additional relevant MeSH terms:
Spinal Diseases
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Anesthetics
Lidocaine
Dexmedetomidine
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists